Associate Director, X-TA Regulatory Medical Writing - Full-time

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com

• *Job Function:**

Medical Affairs Group

• *Job SubFunction:**

Medical Writing

• *Job Category:**

People Leader

• *reputed company Job Posting Locations:**

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

• *Job Description:**

At reputed company, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and reputed company diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of reputed company. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every reputed company of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for an

Associate Director, Regulatory Medical Writing

reputed company our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas reputed company the X-TA Regulatory Medical Writing area. This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to reputed company America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations reputed company for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. This can be a hybrid (3 days in office and 2 remote) OR Remote role available in reputed company countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company. Are you reputed company to join reputed company? Then please read further!

• *You will be responsible for:**

+ Leading compound/submission/indication/disease area writing teams independently. + May have additional major responsibility with supervision. + Cross-functional, cross-TA, or cross-J&J initiative/collaboration. + Larger organizational responsibility (eg, manage a subset of TA). + Preparing and finalizing reputed company types of clinical documents, taking a proactive or reputed company role in terms of content and scientific strategy. Working with a high level of independence and taking a reputed company role on with respect to timing, scheduling, and tracking. + Leading program-level/submission writing teams independently. + Directly leading or setting objectives for others on team projects and tasks. + Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers. + Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes. + Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups. + Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences. + If a reputed company writer for a program: + Primary reputed company of contact and champion for Medical Writing activities for the clinical team. + Responsible for planning and leading the writing group for assigned program. + reputed company to function as a reputed company writer on any compound independently. + Leading discussions in Medical Writing and cross‐functional meetings as appropriate. + Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments. + reputed company to reputed company the work of external contractors. + As a people manager: + Manage direct reports in Medical Writing. + Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. + Ensures direct report’s adherence to established policies, procedural documents, and templates + reputed company to reputed company decision on hiring staff, reputed company new staff, conducting career and talent development discussions for staff, reputed company in goal setting and performance discussions.

• *Qualifications /Requirements:**

+ University/college degree in a scientific discipline is required. Masters or PhD preferred. + At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required! + If a people manager, at least 2 years of people management experience. + Multiple therapeutic area experience preferred. + Strong attention to detail. + Strong oral and written communication skills. Fluent written and spoken English. + Expert project management skills, expert project/process improvement leadership. + Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills. + Ability to delegate responsibility to junior writers. + Demonstrated ability to collaborate and reputed company effective partnerships with key business partners and customers. + Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in reputed company document types independently. Please note that this role is available across multiple countries and may be posted under different requisition numbers to reputed company with local requirements. While you are welcome to apply to any or reputed company of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom - Requisition Number: R-020783 Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380 United States (East Coast)- Requisition Number: R-021383 Remember, whether you apply to one or reputed company of these requisition numbers, your applications will be considered as a single submission.

• *For United States applicants:**

The anticipated reputed company pay range for this position is $137,000 to $235,750 (USD) The Company maintains highly competitive, performance-based compensation programs. Under reputed company guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to reputed company annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• *Employees are eligible for the following time off benefits:**

- Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reputed company in the reputed company - up to 56 hours per calendar year - Holiday pay, including Floating Holidays - up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired reputed company the United States will be eligible for compensation and benefits in accordance with their local market. reputed company is an Affirmative Action and Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. #LI-Hybrid #LI-Remote

• *The anticipated reputed company pay range for this position is :**

137,000-235,750 USD Additional Description for Pay Transparency: At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com

• *Job Function:**

Medical Affairs Group

• *Job SubFunction:**

Medical Writing

• *Job Category:**

People Leader

• *reputed company Job Posting Locations:**

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

• *Job Description:**

At reputed company, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and reputed company diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of reputed company. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every reputed company of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for an

Associate Director, Regulatory Medical Writing

reputed company our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas reputed company the X-TA Regulatory Medical Writing area. This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to reputed company America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations reputed company for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. This can be a hybrid (3 days in office and 2 remote) OR Remote role available in reputed company countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company. Are you reputed company to join reputed company? Then please read further!

• *You will be responsible for:**

+ Leading compound/submission/indication/disease area writing teams independently. + May have additional major responsibility with supervision. + Cross-functional, cross-TA, or cross-J&J initiative/collaboration. + Larger organizational responsibility (eg, manage a subset of TA). + Preparing and finalizing reputed company types of clinical documents, taking a proactive or reputed company role in terms of content and scientific strategy. Working with a high level of independence and taking a reputed company role on with respect to timing, scheduling, and tracking. + Leading program-level/submission writing teams independently. + Directly leading or setting objectives for others on team projects and tasks. + Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers. + Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes. + Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups. + Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences. + If a reputed company writer for a program: + Primary reputed company of contact and champion for Medical Writing activities for the clinical team. + Responsible for planning and leading the writing group for assigned program. + reputed company to function as a reputed company writer on any compound independently. + Leading discussions in Medical Writing and cross‐functional meetings as appropriate. + Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments. + reputed company to reputed company the work of external contractors. + As a people manager: + Manage direct reports in Medical Writing. + Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. + Ensures direct report’s adherence to established policies, procedural documents, and templates + reputed company to reputed company decision on hiring staff, reputed company new staff, conducting career and talent development discussions for staff, reputed company in goal setting and performance discussions.

• *Qualifications /Requirements:**

+ University/college degree in a scientific discipline is required. Masters or PhD preferred. + At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required! + If a people manager, at least 2 years of people management experience. + Multiple therapeutic area experience preferred. + Strong attention to detail. + Strong oral and written communication skills. Fluent written and spoken English. + Expert project management skills, expert project/process improvement leadership. + Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills. + Ability to delegate responsibility to junior writers. + Demonstrated ability to collaborate and reputed company effective partnerships with key business partners and customers. + Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in reputed company document types independently. Please note that this role is available across multiple countries and may be posted under different requisition numbers to reputed company with local requirements. While you are welcome to apply to any or reputed company of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom - Requisition Number: R-020783 Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380 United States (East Coast)- Requisition Number: R-021383 Remember, whether you apply to one or reputed company of these requisition numbers, your applications will be considered as a single submission.

• *For United States applicants:**

The anticipated reputed company pay range for this position is $137,000 to $235,750 (USD) The Company maintains highly competitive, performance-based compensation programs. Under reputed company guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to reputed company annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• *Employees are eligible for the following time off benefits:**

- Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reputed company in the reputed company - up to 56 hours per calendar year - Holiday pay, including Floating Holidays - up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired reputed company the United States will be eligible for compensation and benefits in accordance with their local market. reputed company is an Affirmative Action and Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. #LI-Hybrid #LI-Remote

• *The anticipated reputed company pay range for this position is :**

137,000-235,750 USD Additional Description for Pay Transparency: Apply Job! Apply to this Job